Assessing the Effects of a Multisectoral Agricultural Intervention on the Reproductive and Sexual Health of Adolescent Girls and Young Women

NCT ID: NCT06953310

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2028-01-31

Brief Summary

In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW. Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes. Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health. In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training. The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts. The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2. Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3. Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention. The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".

Conditions

Sexually Transmitted Infection (STI); HIV; Food Insecurity; Mental Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Shamba Maisha Intervention

The Shamba Maisha Intervention inervention has three key parts:

1. Farming Equipment and Training: The study provide families with water pumps, seeds, and other farming tools to improve their ability to grow food. Caregivers and girls will also get training on how to use these tools.

2. School-based Farming: Girls will participate in practical farming activities at school, where they can learn and practice the farming skills. This also benefits the entire school because the crops grown can be used to provide food for students.

3. Caregiver and Adolescent Relationship Strengthening: Families will take part in special sessions where they will learn how to improve their communication, reduce stress, and talk about important topics like sexual health.

Group Type: EXPERIMENTAL

Shamba Maisha

Intervention Type: OTHER

The Shamba Maisha Intervention intervention has three key parts:

Farming Equipment and Training: The study will provide families with water pumps, seeds, and other farming tools to improve their ability to grow food. Caregivers and girls will also get training on how to use these tools.

School-based Farming: Girls will participate in practical farming activities at school, where they can learn and practice the farming skills. This also benefits the entire school because the crops grown can be used to provide food for students.

Caregiver and Adolescent Relationship Strengthening: Families will take part in special sessions where they will learn how to improve their communication, reduce stress, and talk about important topics like sexual health.

Control Arm

Control participants and schools randomized to the control condition will have the opportunity to receive the full intervention at the conclusion of data collection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Shamba Maisha

The Shamba Maisha Intervention intervention has three key parts:

Farming Equipment and Training: The study will provide families with water pumps, seeds, and other farming tools to improve their ability to grow food. Caregivers and girls will also get training on how to use these tools.

School-based Farming: Girls will participate in practical farming activities at school, where they can learn and practice the farming skills. This also benefits the entire school because the crops grown can be used to provide food for students.

Caregiver and Adolescent Relationship Strengthening: Families will take part in special sessions where they will learn how to improve their communication, reduce stress, and talk about important topics like sexual health.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Adolescent Girls and Young women (AGYW):

• AGYW assigned female at birth
• Between 15-19 years of age at enrollment
• Attending the selected schools with at least 18 months remaining of schooling
• STI-uninfected and not pregnant at baseline
• Has an adult caregiver willing to participate
• Demonstrates moderate to severe FI based on the Household Food Insecurity Access Scale (HFIAS), and/or malnutrition (BMI less than two standard deviations below the mean for age-specific BMI

Caregiver:

• At least 18 years old.
• At least 1 AGYW aged 15-19 years old attending the selected schools
• household has access to farming land
• household has available surface water in the form of lakes, rivers, ponds, or shallow wells (home is 200m from permanent water source)

Exclusion Criteria

• AGYW or adult caregivers who have inadequate cognitive and/or hearing capacity to complete planned study procedures
• AGYW or adult caregivers who do not speak Dholuo, Kiswahili, or English
• Married AGYW and those who serve as heads of households
• AGYW who are pregnant at screening

Adolescent girls who test positive for gonorrhea or chlamydia at screening will be invited to re-screen at least 14 days after receiving treatment and will be eligible to enroll if they have a confirmatory negative STI test.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheri Weiser, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Jennifer Velloza, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Maricianah Onono, MBChB, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Locations

Kenya Medical Research Institute (KEMRI)

Kisumu, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

Rachel L Burger, MHS

Role: CONTACT

rachel.burger@ucsf.edu

415-535-2650

Jennifer Velloza, PhD, MPH

Role: CONTACT

jennifer.velloza@ucsf.edu

917-392-3561

Facility Contacts

Maricianah Onono, MBChB, MS, PhD

Role: primary

maricianah@gmail.com

+254732390992

Elly Weke, MS

Role: backup

otielly@yahoo.com

254718441874

References

Cohen CR, Weke E, Frongillo EA, Sheira LA, Burger R, Mocello AR, Wekesa P, Fisher M, Scow K, Thirumurthy H, Dworkin SL, Shade SB, Butler LM, Bukusi EA, Weiser SD. Effect of a Multisectoral Agricultural Intervention on HIV Health Outcomes Among Adults in Kenya: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2246158. doi: 10.1001/jamanetworkopen.2022.46158.

Reference Type: BACKGROUND

PMID: 36508217 (View on PubMed)

Onono MA, Sheira L, Frongilio EA, Odhiambo G, Wekesa P, Conroy A, Bukusi EA, Cohen CR, Weiser SD. Effect of improving food security on parenting practices and caregiver-adolescent relationships: qualitative findings of an income-generating agricultural intervention in rural Kenya. BJPsych Open. 2024 Dec 26;11(1):e10. doi: 10.1192/bjo.2024.802.

Reference Type: BACKGROUND

PMID: 39721953 (View on PubMed)

Onono MA, Frongillo EA, Sheira LA, Odhiambo G, Wekesa P, Conroy AA, Cohen CR, Bukusi EA, Weiser SD. Links between Household-Level Income-Generating Agricultural Intervention and the Psychological Well-Being of Adolescent Girls in Human Immunodeficiency Virus-Affected Households in Southwestern Kenya: A Qualitative Inquiry. J Nutr. 2023 Dec;153(12):3595-3603. doi: 10.1016/j.tjnut.2023.10.008. Epub 2023 Oct 18.

Reference Type: BACKGROUND

PMID: 37863268 (View on PubMed)

Onono MA, Odhiambo G, Sheira L, Conroy A, Neilands TB, Bukusi EA, Weiser SD. The role of food security in increasing adolescent girls' agency towards sexual risk taking: qualitative findings from an income generating agricultural intervention in southwestern Kenya. BMC Public Health. 2021 Nov 6;21(1):2028. doi: 10.1186/s12889-021-12051-6.

Reference Type: BACKGROUND

PMID: 34742285 (View on PubMed)

Related Links

https://shambamaisha.ucsf.edu/

Related Info

Other Identifiers

R01MH138256

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01MH138256

Identifier Type: NIH

Identifier Source: org_study_id

View Link